Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial
BACKGROUND: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Ele...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390000/ https://www.ncbi.nlm.nih.gov/pubmed/25872782 http://dx.doi.org/10.1186/s13063-015-0633-1 |
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author | Gerritsen, Arja de Rooij, Thijs Dijkgraaf, Marcel G Busch, Olivier R Bergman, Jacques J Ubbink, Dirk T van Duijvendijk, Peter Erkelens, G Willemien Molenaar, I Quintus Monkelbaan, Jan F Rosman, Camiel Tan, Adriaan C Kruyt, Philip M Bac, Dirk Jan Mathus-Vliegen, Elisabeth M Besselink, Marc G |
author_facet | Gerritsen, Arja de Rooij, Thijs Dijkgraaf, Marcel G Busch, Olivier R Bergman, Jacques J Ubbink, Dirk T van Duijvendijk, Peter Erkelens, G Willemien Molenaar, I Quintus Monkelbaan, Jan F Rosman, Camiel Tan, Adriaan C Kruyt, Philip M Bac, Dirk Jan Mathus-Vliegen, Elisabeth M Besselink, Marc G |
author_sort | Gerritsen, Arja |
collection | PubMed |
description | BACKGROUND: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs. METHODS/DESIGN: The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications. DISCUSSION: The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes. TRIAL REGISTRATION: Dutch Trial Register: NTR4420, date registered 5-feb-2014 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0633-1) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4390000 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-43900002015-04-09 Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial Gerritsen, Arja de Rooij, Thijs Dijkgraaf, Marcel G Busch, Olivier R Bergman, Jacques J Ubbink, Dirk T van Duijvendijk, Peter Erkelens, G Willemien Molenaar, I Quintus Monkelbaan, Jan F Rosman, Camiel Tan, Adriaan C Kruyt, Philip M Bac, Dirk Jan Mathus-Vliegen, Elisabeth M Besselink, Marc G Trials Study Protocol BACKGROUND: Gastroparesis is common in surgical patients and frequently leads to the need for enteral tube feeding. Nasoenteral feeding tubes are usually placed endoscopically by gastroenterologists, but this procedure is relatively cumbersome for patients and labor-intensive for hospital staff. Electromagnetic (EM) guided bedside placement of nasoenteral feeding tubes by nurses may reduce patient discomfort, workload and costs, but randomized studies are lacking, especially in surgical patients. We hypothesize that EM guided bedside placement of nasoenteral feeding tubes is at least as effective as endoscopic placement in surgical patients, at lower costs. METHODS/DESIGN: The CORE trial is an investigator-initiated, parallel-group, pragmatic, multicenter randomized controlled non-inferiority trial. A total of 154 patients admitted to gastrointestinal surgical wards in five hospitals, requiring nasoenteral feeding, will be randomly allocated to undergo EM guided or endoscopic nasoenteral feeding tube placement. Primary outcome is reinsertion of the feeding tube, defined as the insertion of an endoscope or tube in the nose/mouth and esophagus for (re)placement of the feeding tube (e.g. after failed initial placement or dislodgement or blockage of the tube). Secondary outcomes include patient-reported outcomes, costs and tube (placement) related complications. DISCUSSION: The CORE trial is designed to generate evidence on the effectiveness of EM guided placement of nasoenteral feeding tubes in surgical patients and the impact on costs as compared to endoscopic placement. The trial potentially offers a strong argument for wider implementation of this technique as method of choice for placement of nasoenteral feeding tubes. TRIAL REGISTRATION: Dutch Trial Register: NTR4420, date registered 5-feb-2014 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0633-1) contains supplementary material, which is available to authorized users. BioMed Central 2015-03-26 /pmc/articles/PMC4390000/ /pubmed/25872782 http://dx.doi.org/10.1186/s13063-015-0633-1 Text en © Gerritsen et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Gerritsen, Arja de Rooij, Thijs Dijkgraaf, Marcel G Busch, Olivier R Bergman, Jacques J Ubbink, Dirk T van Duijvendijk, Peter Erkelens, G Willemien Molenaar, I Quintus Monkelbaan, Jan F Rosman, Camiel Tan, Adriaan C Kruyt, Philip M Bac, Dirk Jan Mathus-Vliegen, Elisabeth M Besselink, Marc G Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title | Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title_full | Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title_fullStr | Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title_full_unstemmed | Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title_short | Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial |
title_sort | electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (core trial): study protocol for a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4390000/ https://www.ncbi.nlm.nih.gov/pubmed/25872782 http://dx.doi.org/10.1186/s13063-015-0633-1 |
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